Director, Biotechnology, Engineering

Director, Manufacturing Science & Technology (MSAT)

Massachusetts, United States

Full-time | On-site

This is a senior leadership position within a growing CDMO, responsible for driving technical operations across process transfer, process validation, manufacturing support, process characterization, and lifecycle management for a portfolio of biologics products. This is a critical role in ensuring robust manufacturing processes, successful client technology transfers, and the continued expansion of the organization's commercial manufacturing capabilities. The organization partners with emerging biotech and established pharmaceutical companies to develop and manufacture complex biologic products across clinical and commercial stages

• Lead the MSAT function supporting biologics manufacturing operations across clinical and commercial programs
• Oversee technology transfer activities from client process handoff through GMP manufacturing implementation
• Drive process characterization, process validation, continued process verification, and lifecycle management activities
• Provide technical leadership for manufacturing investigations, deviation resolution, and CAPA implementation
• Support scale-up activities and process performance improvements to enhance yield, robustness, and efficiency
• Partner closely with Manufacturing, Quality, Process Development, Engineering, Regulatory Affairs, and Program Management teams
• Develop and execute MSAT strategies aligned with operational and commercial growth objectives
• Build, mentor, and develop a high-performing team of scientists and engineers
• Ensure compliance with FDA, EMA, ICH, and global cGMP requirements
• Support regulatory inspections, client audits, and technical responses to health authorities
• Drive data-driven decision-making and implementation of continuous improvement initiatives
• Manage departmental resources, budgets, and project priorities

• Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or related discipline (Master's or PhD preferred)
• 10+ years of experience within biologics manufacturing, process development, or MSAT environments
• Demonstrated experience supporting monoclonal antibodies, recombinant proteins, or other biologic drug substances and drug products
• Prior experience within a CDMO or contract manufacturing environment strongly preferred
• Proven track record leading technology transfer and process validation programs
• 5+ years of people leadership experience, including development of technical teams
• Strong understanding of upstream and/or downstream biologics manufacturing processes
• Experience supporting GMP operations, investigations, change controls, and regulatory inspections
• Knowledge of process performance monitoring, statistical analysis, and continued process verification principles
• Excellent communication, stakeholder management, and client-facing skills

• Join a rapidly expanding biologics CDMO supporting innovative therapeutic programs
• Opportunity to influence technical strategy and operational excellence across multiple manufacturing sites
• High visibility role with direct interaction with executive leadership and external clients
• Strong pipeline of clinical and commercial biologics programs
• Significant opportunities for team building and career progression
• Competitive compensation package including bonus and comprehensive benefits